Home GUDID 00198506074844 ELMED INCORPORATED
Primary DI 00198506074844
Brand ELMED INCORPORATED
Company ELMED INCORPORATED
Model 23-242104
Catalog number 23-242104
Device description "THIN OSTEOTOME; 12.5MM X 7-3/4"""
Published 2025-01-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KDG Chisel (Osteotome)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDG Chisel (Osteotome) General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00198506074844 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00198506074844 00198506074844 198506074844 0198506074844
GMDN Terms# Term, Definition table Term Definition Orthopaedic osteotome A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 049290364 Device count 1 Premarket exempt true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B382SD921381110 Surgical Direct Surgical Direct, Inc. KDG 2026-02-12 B382SD9144841130 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9144841180 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9144841190 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD921613120 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9233201100 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 B382SD9233201110 Surgical Direct Surgical Direct, Inc. KDG 2025-11-05 00198506086465 ELMED INCORPORATED ELMED INCORPORATED KDG 2025-11-05 B382SD62622020 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622040 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622060 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622070 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622080 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622090 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622100 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 B382SD62622120 Surgical Direct Surgical Direct, Inc. KDG 2025-10-14 00810158217577 PRINCETON Princeton Medical Group, Inc. KDG 2025-10-08 00810158216938 PRINCETON Princeton Medical Group, Inc. KDG 2025-09-10 10840199528834 Comfort Plus Chisel KOROS U.S.A., INC. KDG 2025-01-31 10888277381339 MEDLINE MEDLINE INDUSTRIES, INC. KDG 2025-01-29 10888277392304 MEDLINE MEDLINE INDUSTRIES, INC. KDG 2025-01-29 10840199511423 Chisel KOROS U.S.A., INC. KDG 2024-12-31 10840199511430 Chisel KOROS U.S.A., INC. KDG 2024-12-31 10840199527394 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527400 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527417 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527424 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527431 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527448 Osteotome KOROS U.S.A., INC. KDG 2024-12-31 10840199527455 Osteotome KOROS U.S.A., INC. KDG 2024-12-31
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